Schizophrenia Pipeline 2025: MOA, ROA, FDA-Approved Drugs, And Clinical Trial Progress Assessment By Delveinsight Reviva Pharma, Minerva Neurosciences, Karuna Therapeutics, Acadia Pharma, Boehringer

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(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Schizophrenia pipeline constitutes 55+ key companies continuously working towards developing 60+ Schizophrenia treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

“Schizophrenia Pipeline Insight, 2025 " report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Schizophrenia Market.

The Schizophrenia Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Schizophrenia Pipeline Report:

• Companies across the globe are diligently working toward developing novel Schizophrenia treatment therapies with a considerable amount of success over the years.

• Schizophrenia companies working in the treatment market are Reviva Pharmaceuticals, Minerva Neurosciences, Karuna Therapeutics, Acadia Pharmaceuticals, Boehringer Ingelheim, Sunovion Pharmaceuticals (Sumitomo Pharma)/Otsuka Pharmaceutical, Lyndra Therapeutics, Laboratorios Farmacéuticos Rovi, Newron Pharmaceuticals, Cerevel Therapeutics, AstraZeneca, Eli Lilly and Company, Karuna Therapeutics, Neurocrine Biosciences, and others , are developing therapies for the Schizophrenia treatment

• Emerging Schizophrenia therapies in the different phases of clinical trials are- RP5063 (brilaroxazine), MIN-101 (roluperidone), KarXT (xanomeline-trospium), NUPLAZID (pimavanserin), ICELPERTIN (BI-425809), SEP-363856 (ulotaront), OKEDI (risperidone ISM), LYN-005, NW-3509/NW-3509A (evenamide), CVL-231 (emraclidine), Seroquel Sustained Release, Intramuscular Olanzapine Depot, Xanomeline and Trospium Chloride Capsules, NBI-1117568, and others are expected to have a significant impact on the Schizophrenia market in the coming years.

• In May 2025, Neurocrine Biosciences initiated a Phase III registrational program to evaluate the investigational oral muscarinic M4 selective orthosteric agonist, NBI-1117568, for treating schizophrenia in adults. This double-blind, placebo-controlled trial will assess the therapy's safety, tolerability, and efficacy in patients experiencing an acute exacerbation or relapse of schizophrenia symptoms. Approximately 280 participants are expected to be enrolled. The primary endpoint is the reduction in the Positive and Negative Syndrome Scale (PANSS) from baseline, with improvement in the Clinical Global Impression of Severity (CGI-S) scale as a key secondary endpoint.

• In May 2025, Vanda Pharmaceuticals reported that the FDA has accepted the New Drug Application (NDA) for Bysanti (milsaperidone) without raising any review concerns. The agency has scheduled February 21, 2026, as the decision date. Milsaperidone, a novel chemical entity and active metabolite of iloperidone, has demonstrated dose-dependent bioequivalence in clinical studies.

• In April 2025, CMG Pharmaceutical , a subsidiary of CHA Biotech, secured FDA approval for Mezofy (formerly Depipzo), an oral film therapy for schizophrenia. Formulated with aripiprazole, it dissolves in the mouth, improving adherence without requiring water.

• In March 2025, Vanda Pharmaceuticals Inc. has submitted a New Drug Application (NDA) to the FDA seeking marketing approval for Bysanti (milsaperidone) as a treatment for acute bipolar I disorder and schizophrenia, backed by several clinical studies demonstrating its safety and efficacy.

• In March 2025, LB Pharmaceuticals Inc., a clinical-stage biopharma company focused on developing innovative treatments for neuropsychiatric disorders such as schizophrenia, has shared new positive findings from its NOVA1 Phase 2 clinical trial of LB-102 in patients experiencing acute schizophrenia exacerbations. The data was presented at the 2025 Annual Congress of the Schizophrenia International Research Society (SIRS), currently taking place in Chicago.

• In February 2025, The September 2024 approval of xanomeline-trospium chloride (Cobenfy; Bristol Myers Squibb) marks the first novel schizophrenia treatment in 70 years. While some experts have welcomed the milestone, others remain cautious. Unlike traditional antipsychotics that target dopamine D2 receptors, this therapy works through muscarinic acetylcholine receptors, offering a distinct mechanism of action.

• In January 2025, German pharmaceutical leader Boehringer Ingelheim revealed that its investigational drug iclepertin, intended to treat cognitive impairment in schizophrenia patients, did not meet any primary or secondary endpoints across three Phase III trials. The CONNEX program results showed no significant cognitive or functional improvements over placebo after six months. However, the company noted that iclepertin maintained a favorable safety profile.

• In January 2025, Segal Trials, a private clinical research organization focused on acute schizophrenia and other psychiatric conditions, has shared its enrollment performance data from its involvement in NOVA-a Phase 2 dose-finding study in adults with acute schizophrenia assessing LB-102, a once-daily oral small molecule and potential first-in-class benzamide antipsychotic.

Schizophrenia Overview

Schizophrenia is a chronic and severe mental health disorder that affects how a person thinks, feels, and behaves. It is characterized by symptoms such as hallucinations (hearing or seeing things that are not real), delusions (false beliefs), disorganized thinking, impaired concentration, reduced emotional expression, and social withdrawal. The condition often appears in late adolescence or early adulthood and can significantly impact daily functioning and quality of life. While its exact cause is unknown, factors like genetics, brain chemistry, and environment play a role. Treatment typically involves antipsychotic medications, psychotherapy, and psychosocial support to help manage symptoms and improve functioning.

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Emerging Schizophrenia Drugs Under Different Phases of Clinical Development Include:

• RP5063 (brilaroxazine): Reviva Pharmaceuticals

• MIN-101 (roluperidone): Minerva Neurosciences

• KarXT (xanomeline-trospium): Karuna Therapeutics

• NUPLAZID (pimavanserin): Acadia Pharmaceuticals

• ICELPERTIN (BI-425809): Boehringer Ingelheim

• SEP-363856 (ulotaront): Sunovion Pharmaceuticals (Sumitomo Pharma)/Otsuka Pharmaceutical

• OKEDI (risperidone ISM): Laboratorios Farmacéuticos Rovi

• LYN-005: Lyndra Therapeutics

• NW-3509/NW-3509A (evenamide): Newron Pharmaceuticals

• CVL-231 (emraclidine): Cerevel Therapeutics

• Seroquel Sustained Release: AstraZeneca

• Intramuscular Olanzapine Depot: Eli Lilly and Company

• Xanomeline and Trospium Chloride Capsules: Karuna Therapeutics

• NBI-1117568: Neurocrine Biosciences

Schizophrenia Route of Administration

Schizophrenia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

• Oral

• Parenteral

• Intravenous

• Subcutaneous

• Topical

Schizophrenia Molecule Type

Schizophrenia Products have been categorized under various Molecule types, such as

• Monoclonal Antibody

• Peptides

• Polymer

• Small molecule

• Gene therapy

Schizophrenia Pipeline Therapeutics Assessment

• Schizophrenia Assessment by Product Type

• Schizophrenia By Stage and Product Type

• Schizophrenia Assessment by Route of Administration

• Schizophrenia By Stage and Route of Administration

• Schizophrenia Assessment by Molecule Type

• Schizophrenia by Stage and Molecule Type

DelveInsight's Schizophrenia Report covers around 60+ products under different phases of clinical development like

• Late-stage products (Phase III)

• Mid-stage products (Phase II)

• Early-stage product (Phase I)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Schizophrenia product details are provided in the report. Download the Schizophrenia pipeline report to learn more about the emerging Schizophrenia therapies

Some of the key companies in the Schizophrenia Therapeutics Market include:

Key companies developing therapies for Schizophrenia are - Otsuka Pharmaceutical Co., Ltd., AstraZeneca, Sumitomo Dainippon Pharma, Johnson & Johnson, Bristol-Myers Squibb, Eli Lilly and Company, Alkermes Plc, Vanda Pharmaceuticals Inc., and others.

Schizophrenia Pipeline Analysis:

The Schizophrenia pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Schizophrenia with aggregate therapies developed by each company for the same.

• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Schizophrenia Treatment.

• Schizophrenia key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Schizophrenia Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Schizophrenia market.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Schizophrenia drugs and therapies

Schizophrenia Pipeline Market Drivers

• Increasing popularity among individuals for long-acting injectable (LAI) antipsychotics are key factors driving growth of the global schizophrenia drugs market.

Schizophrenia Pipeline Market Barriers

• WHO's Comprehensive Mental Health Action Plan 2013- 2030 will further enhance the awareness about mental health by ensuring 100 million more people have access to quality and affordable care for mental health conditions.

Scope of Schizophrenia Pipeline Drug Insight

• Coverage: Global

• Key Schizophrenia Companies: Reviva Pharmaceuticals, Minerva Neurosciences, Karuna Therapeutics, Acadia Pharmaceuticals, Boehringer Ingelheim, Sunovion Pharmaceuticals (Sumitomo Pharma)/Otsuka Pharmaceutical, Lyndra Therapeutics, Laboratorios Farmacéuticos Rovi, Newron Pharmaceuticals, Cerevel Therapeutics, AstraZeneca, Eli Lilly and Company, Karuna Therapeutics, Neurocrine Biosciences, and others

• Key Schizophrenia Therapies: RP5063 (brilaroxazine), MIN-101 (roluperidone), KarXT (xanomeline-trospium), NUPLAZID (pimavanserin), ICELPERTIN (BI-425809), SEP-363856 (ulotaront), OKEDI (risperidone ISM), LYN-005, NW-3509/NW-3509A (evenamide), CVL-231 (emraclidine), Seroquel Sustained Release, Intramuscular Olanzapine Depot, Xanomeline and Trospium Chloride Capsules, NBI-1117568, and others

• Schizophrenia Therapeutic Assessment: Schizophrenia current marketed and Schizophrenia emerging therapies

• Schizophrenia Market Dynamics: Schizophrenia market drivers and Schizophrenia market barriers

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Table of Contents

1. Schizophrenia Report Introduction

2. Schizophrenia Executive Summary

3. Schizophrenia Overview

4. Schizophrenia- Analytical Perspective In-depth Commercial Assessment

5. Schizophrenia Pipeline Therapeutics

6. Schizophrenia Late Stage Products (Phase II/III)

7. Schizophrenia Mid Stage Products (Phase II)

8. Schizophrenia Early Stage Products (Phase I)

9. Schizophrenia Preclinical Stage Products

10. Schizophrenia Therapeutics Assessment

11. Schizophrenia Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Schizophrenia Key Companies

14. Schizophrenia Key Products

15. Schizophrenia Unmet Needs

16 . Schizophrenia Market Drivers and Barriers

17. Schizophrenia Future Perspectives and Conclusion

18. Schizophrenia Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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